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510(k) Data Aggregation

    K Number
    K102189
    Device Name
    POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM
    Manufacturer
    LATEXX MANUFACTURING SDN.BHD.
    Date Cleared
    2012-03-14

    (590 days)

    Product Code
    LZC
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LATEXX MANUFACTURING SDN.BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested chemotherapy drugs are as follows: Cisplatin, 1.0 mg/ml ≥ 240 Cyclophosphamide (Cytoxan), 20.0 mg/ml ≥ 240 Cytarabine, 100 mg/ml ≥ 240 Cytovene, 10 mg/ml ≥ 240 Dacarbazine (DTIC), 10.0 mg/ml ≥ 240 Docetaxel, 10.0 mg/ml ≥ 240 Doxorubicin Hydrochloride, 2.0 mg/ml ≥ 240 Etoposide (Toposar), 20.0 mg/ml ≥ 240 Fluorouracil, 50.0 mg/ml ≥ 240 Ifosfamide, 50.0 mg/ml ≥ 240 Irinotecan Hydrochloride, 20 mg/ml ≥ 240 Mechlorethamine HCI, 1.0 mg/ml ≥ 240 Methotrexate, 25 mg/ml ≥ 240 Mitomycin C, 0.5 mg/ml ≥ 240 Mitoxantrone, 2 mg/ml ≥ 240 Oxaliplatin, 5mg/ml ≥ 240 Paclitaxel (Taxol), 6.0 mg/ml ≥ 240 ThioTEPA 75.8 Vincristine Sulfate, 1.0 mg/ml ≥ 240 Vinorelbine, 10 mg/ml ≥ 240 Low Permeation Time (minutes) 1.7 Carmustine (BCNU), 3.3 mg/ml Please note that the following drug has an extremely low permeation time: Carmustine (BCNU) 1.7 (mins)
    Device Description
    Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim, meeting all the requirements of ASTM standards D6319-10 and ASTM D6124-06. The gloves are non-sterile, single-use, disposable devices.
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    K Number
    K101645
    Device Name
    NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF
    Manufacturer
    LATEXX MANUFACTURING SDN.BHD.
    Date Cleared
    2010-08-26

    (76 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LATEXX MANUFACTURING SDN.BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove and Protein Labeling Claim of 50 Micrograms or Les Protein is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
    Device Description
    Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove and Protein Labeling Claim of 50 Micrograms or Less Protein is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D-3578-051, Standard Specification for Rubber Examination Gloves. They are made from natural rubber latex. They are natural white in color and are powder free.
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    K Number
    K034052
    Device Name
    BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
    Manufacturer
    LATEXX MANUFACTURING SDN.BHD.
    Date Cleared
    2004-03-15

    (76 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LATEXX MANUFACTURING SDN.BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Black Colour Powder Free Nitrile Rubber Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
    Device Description
    Black Colour Powder Free Nitrile Rubber Examination Glove as described in this 510k Notification is substantially equivalent to the current Class I patient examination glove bearing the product code 80LZA (21CFR 880.6250). It meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves. They are made from nitrile rubber compound. They are black in colour and are powder free.
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    K Number
    K022346
    Device Name
    CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES
    Manufacturer
    LATEXX MANUFACTURING SDN.BHD.
    Date Cleared
    2002-10-18

    (91 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LATEXX MANUFACTURING SDN.BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mint Flavour, Blue Colour Powder Free BarrierPro™ Copolymer Rubber Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
    Device Description
    Cleantexx <sup>TM</sup> Mint Flavour, Blue Colour Powder Free Barrier<br>Pro <sup>TM</sup> Polybutadiene Copolymer Examination Gloves<br>meets all the current specifications listed under the ASTM<br>Specification D 6319-00a, Standard Specification for Nitrile<br>Examination Gloves for Medical Application. They are<br>made from BarrierPro <sup>TM</sup> synthetic copolymer rubber latex, a<br>polybutadiene based copolymer. They are mint flavour,<br>blue in colour, are powder free.
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    K Number
    K022102
    Device Name
    CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES, BLUE COLOUR
    Manufacturer
    LATEXX MANUFACTURING SDN.BHD.
    Date Cleared
    2002-08-22

    (55 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LATEXX MANUFACTURING SDN.BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K022347
    Device Name
    MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES
    Manufacturer
    LATEXX MANUFACTURING SDN.BHD.
    Date Cleared
    2002-08-15

    (27 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LATEXX MANUFACTURING SDN.BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powdered Nitrile Rubber Examination Glove, Green Colour, is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
    Device Description
    MedtexxTM Powdered Green Colour Nitrile Rubber Examination Glove meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from nitrile rubber latex compound. They are green in color and are powdered.
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    K Number
    K022548
    Device Name
    MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
    Manufacturer
    LATEXX MANUFACTURING SDN.BHD.
    Date Cleared
    2002-08-15

    (14 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LATEXX MANUFACTURING SDN.BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blue Colour Powder Free Nitrile Rubber Examination Gloves is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
    Device Description
    Medtexx™ Blue Colour Powder Free Nitrile Rubber Examination Glove is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY (21CFR 880.6250). It meets all the current specifications listed under the ASTM Specification D 6913-00a, Standard Specification for Nitrile Examination Gloves. They are made from nitrile rubber compound. They are blue in color and are powder free.
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    K Number
    K022101
    Device Name
    MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR
    Manufacturer
    LATEXX MANUFACTURING SDN.BHD.
    Date Cleared
    2002-08-02

    (35 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LATEXX MANUFACTURING SDN.BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder Free Nitrile Rubber Examination Glove, Green Colour, is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
    Device Description
    Medtexx™ Powder Free Green Colour Nitrile Rubber Examination Glove meets all the current specifications listed under the ASTM Specification D 6319-00, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from nitrile rubber latex compound. They are natural white in color and are powder free.
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    K Number
    K014087
    Device Name
    LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE
    Manufacturer
    LATEXX MANUFACTURING SDN.BHD.
    Date Cleared
    2002-03-04

    (83 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LATEXX MANUFACTURING SDN.BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Non-chlorinated Power Free Natural Rubber Examination Glove is a single use device intended for medical purposes that is worn on the hand of the healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
    Device Description
    Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove
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    K Number
    K013303
    Device Name
    CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER
    Manufacturer
    LATEXX MANUFACTURING SDN.BHD.
    Date Cleared
    2002-01-23

    (111 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LATEXX MANUFACTURING SDN.BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder Free Synthetic Rubber Latex (BarrierPro™) Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
    Device Description
    CleantexxTM Powder Free Synthetic Rubber Latex Examination Glove meets all the current specifications listed under the ASTM Specification D 6319-00, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from BarrierProTM synthetic rubber latex, a polybutadiene based copolymer. They are natural white in color and are powder free.
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